POS1290 EFFICACY AND SAFETY OF SODIUM THIOSULFATE IN CALCIFIC TENDINITIS OF THE ROTATOR CUFF – AN INTERIM ANALYSIS OF A RANDOMIZED CLINICAL TRIAL
Authors: H. Parente, S. Azevedo, E. Costa, F. Guimarães, C. Dantas Soares, M. Pontes Ferreira, D. Faria, D. Peixoto, J. Tavares-Costa, C. Afonso, F. Teixeira
Journal: Annals of the Rheumatic Diseases (2022)

Background Calcific tendinitis of the rotator cuff is one of the most common causes of shoulder pain. (1) Ultrasound guided percutaneous lavage (UGPL) is indicated when conservative treatments have failed. (2) Recent reports have shown the interest of topical sodium thiosulfate (STS) in the treatment of other diseases characterizes by ectopic calcifications (3, 4, 5). Objectives To assess the efficacy and safety of UGPL with STS versus with saline solution (standard of care - SOC) in calcific tendinitis. Methods Double-blinded randomized clinical trial including adult patients with calcific tendinitis, shoulder pain for more than 3 months and at least one positive shoulder impingement test. Only dense type A calcifications (according to the Molé Classification) &gt; 5 mm in diameter were included. Patients were randomized in two groups: STS and saline solution lavage. Informed consents were collected. Both groups were reevaluated at week 1, month 1 and month 3 after UGPL. Pain Visual Analogue Scale (VAS) at rest and during activities, shoulder range of motion and strength, impingement tests, Disabilities of the Arm, Shoulder and Hand (DASH), DASH-Work, EuroQol five-dimensional (EQ5D) and University of California at Los Angeles (UCLA) scores, ultrasound (US) and radiographic evaluations were performed on all follow up visits. SPSS was used for statistical analysis and significance level was defined as 2-sided p&lt;0.05. Results Twenty-six patients were included, where 76.9% (20) were women, with a mean age of 51.2 (SD=9.0) years old. The mean duration of pain before the procedure was 12.7 months (SD=11.3) (minimum of 3 months and a maximum of 48 months). Fifteen patients (57.7%) were randomized to the control group (SOC) and performed a saline UGPL; the other 11 patients (42.3%) were randomized to the treatment group (STS). Demographic and baseline clinical characteristics are shown in Table 1. Since patient inclusion is dynamic, our sample met 23 patients at week 1 (SOC group = 13 and STS group = 10), 19 patients at month 1 (SOC group = 10 and STS group = 9) and 16 patients at month 3 (SOC group = 8 and STS group = 8). Table 1. Demographic and baseline clinical characteristics. STS lavage (n=11) Saline solution lavage (n=15) p-value Age (years), M (SD) 52.3 (10.6) 50.3 (8.0) NS Sex, female % (n/N) 72.7% (8/11) 80% (12/15) NS Dominant side, right % (n/N) 100% (11/11) 93.3% (14/15) NS Nocturnal pain, yes % (n/N) 100% (11/11) 100% (15/15) NS VAS at rest (0–10), M (SD) 5.7 (2.0) 5.9 (2.1) NS VAS during activities (0–10), M (SD) 7.1 (1.8) 6.0 (2.5) NS DASH Score, M (SD) 60.2 (14.0) 52.6 (13.8) NS DASH-Work Score, M (SD 73.4 (11.0) 63.4 (22.6) NS EQ5D, M (SD) 0.2897 (0.3) 0.4070 (0.2) NS VAS EQ5D (0–100), M (SD) 54 (15.9) 58 (20.0) NS UCLA score, M (SD) 18.7 (4.1) 14.7 (3.3) 0.014 Bursitis, yes % (n/N) 72.7% (8/11) 66.7% (10/15) NS Calcification morphology, % (n/N) Acr-shaped 18.2% (2/11) 40% (6/15) 0.039 Fragmented 18.2% (2/11) 26.7% (4/15) Nodular and dense, well-defined 63.6% (7/11) 33.3% (5/15) Calcification size, median (IQR) 12.6 (5.7) 10.5 (6.3) NS SD: Standard deviation; M: Mean; NS: non-significant; IQR: interquartile range Overall, there were no differences between control (SOC) and treatment group (STS). Both procedures were effective improving pain at rest (p=0.024), EQ5D (p=0.019), DASH-Work (p=0.032) and UCLA scores (p=0.009) and calcification size measured by US (p=0.031) at month 3. No adverse effects or complications were reported on both groups. Conclusion Although well tolerated with no side effects, STS UGPL has failed to show increased benefit for calcific tendinopathy local treatment. Further studies using STS will be needed to ascertain its interest in this disease. This on-going work will be reevaluated with a larger sample. References [1]Louwerens JK et al. J Shoulder Elbow Surg. 2015; 24:1588–93. [2]De Witte PB et al. Am J Sports Med. 2013; 41:1665-73. [3]Ossorio-García L et al. Actas Dermosifiliogr. 2016; 107:359-62. 21. [4]Jost J et al. J Clin Endocrinol Metab. 2016; 101:2810-5. 22. [5]Guigonis V et al. Ann Endocrinol (Paris). 2015; 76:183-4. Disclosure of Interests None declared